Intrauterine contraceptive device (iud)



m- 16, 1969 H. M. HASSON 3,467,089

INTRAUTERINE CONTRACEPTIVE DEVICE (IUD) Filed Feb. 14, 1967 l.\" VIZN'I'(JR. HAS/4N M HASSON /4 T TORNE Y5 United States Patent M 3,467,089INTRAUTERINE CONTRACEPTIVE DEVICE (IUD) Hasan M. Hasson, Chicago, Ill.,assignor to Hollister Incorporated, a corporation of Illinois Filed Feb.14, 1967, Ser. No. 616,023 Int. Cl. A61f 5/46 US. Cl. 128-130 7 ClaimsABSTRACT OF THE DISCLOSURE A wing-type contraceptive intrauterine device(IUD) is provided with the improvement of a second pair of oppositelyextending wings to prevent expulsion. The improved IUD is compatiblewith body tissues, is non-reactive and non-toxic by reason of anexterior surface of silicone rubber. A siliconized Dacron thread isattached for detection and removal of the device. A core of resilient,magnetic material provides improved means for assisting in locating andremoving the IUD. The core provides both resilience, to maintain thewings extended, and deformability to permit pre-setting the contour ofthe wings, as desired.

Brief summary of the invention This invention relates to an intrauterinecontraceptive device (IUD) and more particularly to an IUD that isequipped with means for resisting undesired expulsion, and additionallywith means to assist in locating and removing the same as desired.

Birth control has, in recent years, become a worldwide problem. The pastuse of IUDs has been controversial, but recent studies have tended toestablish their usefulness, particularly in countries that lack arelatively high degree of economic development. The IUD method of birthcontrol is particularly desirable as such a device is relativelyinexpensive, it has a long life in situ, requires no forethought in use,and is not subject to failure of the patient to use. The ideal IUD hasyet to be developed. Conflict still exists as to the most desirableamong a variety of shapes including a ring (Von Grafenberg), a spiralloop (Lippes), and a wing pessary, and among a variety of materialsincluding silver or stainless steel (rings), polyethylene, naturalrubber, etc.

However, the biggest problems associated with IUD usage have been: firstexpulsion or loss of the device from the uterus; second, hostintolerance; third, penetration, or migration, through tissues. Ageneral problem exists in the selection of a material for the IUD whichwill be compatible with the body tissues as well as being non-reactiveand non-toxic.

Thus, one object of this invention is to provide an improved IUD withmeans to prevent expulsion or loss thereof from the uterus.

Another object of this invention is to provide an IUD with an improvedcore structure which achieves resilience where desired while permittingpre-setting of the contour of the IUDs wings as desired.

A further object seeks the provision of an IUD which substantiallyreduces likelihood of host intolerance and of the device embedding andmigration through the surrounding tissue and which is provided withadequate means to facilitate its location and removal as desired.

In the improved device of this application, basically a wing-type IUD isimproved by providing means in the form of opposite extending arms orwings to prevent inadvertent expulsion even under unusual conditionsencountered in some situations of uterine contractions or cervicaldilations which would tend to encourage expulsion or loss of other typesof IUDs. The additional arms or wings may also inhibit any tendency ofmigration of the device through tissues. The core of the IUD is amagnetic spring stainless steel material which provides an efiicientalternative telltale means for locating and removing the device asdesired. The outer surfaces of the IUD are preferably of siliconerubber, such as sold under the trademark Silastic, as such material hasbeen determined to have the desired characteristics and qualities soughtof long life, compatibility with surrounding tissues and body fluids,non-reactiveness and non-toxicity.

In a preferred embodiment, the core of the IUD is defined by twoelongated strips helically entwined to provide a fairly rigid core forthe stem portion of the IUD which provides the resilience to cause thewings to be maintained extended, while the ends of the strips serving ascores of the wings permit of pre-setting the contour of the wings, asdesired.

Further objects and advantages of this invention will become apparent asthe following description proceeds and the features of novelty whichcharacterize this invention will be pointed out with particularity inthe claims .annexed to and forming part of this specification.

Preferred embodiments of the invention are shown in the accompanyingdrawing.

Brief description of the views of the drawing FIG. 1 is a sideelevational view of one form of wings type IUD that embodies thefeatures of this invention.

FIG. 2 is an edge elevational view of the IUD taken looking from theright of FIG. 1.

FIG. 3 is another edge elevational view of the IUD taken looking fromabove of FIG. 1.

FIG. 4 is a cross-sectional view of the IUD taken through the medianplane as indicated by section line 4-4 of FIG. 2.

FIG. 5 is a break-away view allustrating generally the IUD in positionwithin a uterus.

FIG. 6 is a view similar to FIG. 5 showing a typical method and meansfor introducing in the uterus the IUD of FIGS. 1-4.

FIG. 7 is a greatly enlarged cross-sectional view taken on line 77 ofFIG. 1 and illustrating a typical section of one of the IUDs arms.

FIG. 8 is a view similar to FIG. 4 showing a modified form of theinvention.

Detailed description Referring now to the drawing, there is shown inFIG. 1 an intrauterine device (IUD) 10 shaped and pre-formed to providean elongated stem 12, upper wings 14 and 16, and lower wings 18 and 20.Tied around the lower portion of stem 12, adjacent the point of junctionwith the lower wings 18 and 20, is an elongated thread 22 of Dacron orthe like that is coated with silicone rubber and which is provided in alength to extend through the cervix of the uterus and to provide for theuser an indication that the IUD is properly in position, and may also beused to remove the device.

FIG. 5 illustrates in a diagrammatic view, that is partially brokenaway, an attitude that the IUD of FIG. 1 may take when it is properlylodged in the uterus U. FIG. 6, on the other hand, illustrates the meansfor introducing the IUD to the interior of the uterus. In FIG. 6, theIUD is shown with its wings 14-16 and 18-20 folded or disposed so as tobe fitted within an elongated tubular inserter 24 Whose upper end isadapted to be entered into the cervix as shown. The inserter 24 includesa plunger 25 whose action operates to discharge the IUD into positionwithin the uterus U, after which the inserter 24 with plunger 25 thereinmay be withdrawn from the cervix and the IUD will stay in position asillustrated in FIG. 5.

Turning now to the details of construction of the improved IUD 10, thestem 12 includes a relatively stifl core 12a defined by the centralportions oftwo elongated wires 26 and 28 that are intertwined at 30. Theends of the wires 26 and 28 extend beyond the axial ends of core 12a toserve as the cores of the respective wings, thus providing wing cores14a, 16a, 18a and 20a. The outermost ends of the respective wing coresare bent backwardly or curled in a direction axially inwardly or towardan opposite wing as shown at 14b, for example, and so as to insure thatthe outermost tip of each wing core is blunted so as to eliminate, to asgreat an extent as possible, the possibility of piercing of the wall ofthe uterus in the event that the cores of the wings are inadvertentlyexposed.

The respective wings 14 and 16 are inclined radially outwardly andaxially upwardly relative to the upper end of stem 12, and the secondpair of wings 18 and 20 are inclined and project oppositely, namelyoutwardly and axially downwardly of the lower end of the stem 12.

All portions of the two wires 26 and 28 which define the stem core 12aand their respective wing cores are completely encased within a formedjacket or coating of silicone rubber 32. FIG. 7 illustrates a typicalcross section through one of the wings 14 and shows the elongated run ofthe wing core 14a located substantially centrally of the coating andcompletely encased within the formed coating of silicone rubber 32, andwith the exterior periphery of the cross section of the formed coating,dr sirably, being generally elliptical.

The uppermost pair of wings 14 and 16, prior to insertion of the IUDwithin the uterus, are settable by manual pressure and bending andpreferably are to be bent or sprung to the curved position as shown indotted lines in FIG. 1, so that the extended ends of the Wings 14 and 16are curved slightly in the direction as seen in FIG. 5, where the tipsof the wings extend generally slightly downwardly, or toward the otherend of the stem 12, as compared to the direction of projection of thewings 14 and 16 as they originate from the stem 12. Normally, both pairsof resilient wings 14-16, and 18-20 extend in their unrestrained statein opposite diametric directions relative to the longitudinal axis ofthe stern, and each of the wings is inclined axially outwardly of therespective ends of the stern. However, it is believed preferable tospring or bend the upper wings 14-16 to the dotted line position ofFIG. 1. In some instances it will be desirable to also bend the lowerwings 18-20 in the opposite direction, but to a lesser extent, as shownin dotted lines in FIG. 1.

The two wires 26 and 28 preferably are formed of a magnetic springsteel, such as stainless steel, which is resistant to corrosion of bodyfluids. The magnetic feature is desirable since it provides an adequatealternative means for locating and removing the IUD should the thread 22prove insuflicient or should it get lost. If future studies discloseobjections to use of the thread 22, it may be eliminated withoutimpairing the utility of the device disclosed.

FIG. 8 illustrates a modified form of construction in which the coremembers of the wings are in the form of elongated leaf springs ratherthan in the form of intertwined wires as shown in the device of FIGS.1-4. In the form of device of FIG. 8, the IUD has a stem 52 that isformed solely of silicone rubber, and the device is provided with twopairs of wings 54-56 and 58-60. Two lazy-V wire core members areprovided at 53 and 57. The first core member 53 extends into the wings54 and 56 to provide core members 54a and 56a. The second core member 57similarly extends into wings 58 and 60 to define core members 58a and60a; The spring characteristics of core members 53 and 57 are selectedto provide sufiicient resilience to bias the wings toward theunrestrained positions similar to FIG. after the IUD acteristics of thematerial is such that the upper wings 54 and 56, and also the lowerwings 58 and 60, may be pre-formed by the physician toward the archedconditions shown by dotted lines in FIG. 1.

It is contemplated producing such devices as here disclosed in fourdilferent sizes, although more or less sizes may be produced ascircumstances require. The typical variable dimensions which define thesizes are (a) the length of the stem 12, (b) the length of each wing(e.g. 14), (c) the maximum spread between the tips of a pair of wings(e.g. 14 and 16), and (d) the size (diameter) of the core wires (e.g.26). The following table discloses the sizes presently selected:

Maximum Stem Wing Wing Length Length Spread (mm.) (mm.) (mm.)

Additional typical dimensions are, for example, in the b size, the majordiameter of the elliptic section of FIG. 7 is about 2.2-2.4 mm. and theminor diameter of said section is about 1.7-1.8 mm.

While there has been shown and described a particular embodiment of thisinvention, it will be obvious to those skilled in the art that variouschanges and modifications may be made therein without departing from theinvention and, therefore, it is intended in the appended claims to coverall such changes and modifications as fall within the true spirit andscope of the invention.

What I claim as new and desire to secure by Letters Patent of the UnitedStates is:

1. An intrauterine contraceptive device comprising, in combination, anelongated stem, a first pair of elongated resilient wings extending fromone end of said stern, and a second pair of elongated resilient wings atthe other end of said elongated stem for preventing inadvertentexpulsion of said device.

2. A device as in claim 1 wherein each of said two pairs of resilientwings extend in their unrestrained state in opposite diametricdirections of the axis of said stern and inclined axially outwardly ofthe respective ends of said stem.

3. A device as in claim 1 wherein each pair of elongated resilient wingsincluded a core member of magnectie spring steel that is encased in abody of silicone rubber.

4. A device as in claim 1 wherein the periphery of the cross-section ofeach of the resilient wings is generally elliptic.

5. A device as in claim 1 wherein the ends of the resilient wings thatare spaced from the stern are, in their unstressed condition, curvedslightly in a direction generally toward the other end of said stem.

6. A device as in claim 1 wherein each wing is provided with an encasedcore member of spring steel whose outermost end is bent back on itselfso that the outermost reach of the core member within the wing isblunted.

7. A device as in claim 1 wherein the stern and wings are provided witha silicone rubber-encased core member of magnetic spring steel definedby two elongated wires whose central portions are entwined to define thecore of the stem and whose ends assist in defining the four wings of thedevice.

References Cited UNITED STATES PATENTS 662,716 11/1900 Gaedeke 1281301,982,001 11/1934 Haas 128-430 3,364,927 1/ 1968 Robinson 128-130 hasbeen introduced into the uterus. Again, the char- ADELE M. EAGER,Primary Examiner

